The study, which was conducted in both Ireland and Germany, tracked its subjects for 12 months post-treatment. It was the first tinnitus study to access long-term outcomes of a medical device.
The research’s findings showed that 86% of participants who reached the desired compliance level by using the device experienced symptom improvement. Of those participants, 66% reported the relief lasted for up to one year.
The device, now branded as Lenire, was developed by Neuromod Devices. It uses “bimodal neuromodulation” to motivate therapeutic neuroplasticity, which helps the brain adapt to a new experience. The device achieves this in two steps: by sending sound stimulation to the ear with Bluetooth enabled headphones and by sending electric stimulation to the tongue using a small hand-held device.
“After other causes are ruled out, such as a medical illness or tumor, then Lenire can become another successful tool to treat and reduce symptoms of tinnitus.” Hubert Lim, PhD, senior author of the study and associate professor in the department of otolaryngology, head, and neck surgery at the University of Minnesota, tells Verywell.
What Is Tinnitus?
Tinnitus is defined by the American Tinnitus Association (ATA) as the perception of sound when no actual external noise is present. Rather than being a disease in and of itself, tinnitus is a symptom of an underlying medical condition. Tinnitus can be acute (temporary) or chronic (ongoing).
The majority of cases are classified as subjective tinnitus, in which the noises heard in the head or ears are only perceived by the specific patient. This type of tinnitus is often linked to hearing loss but can be triggered by an array of causes.
The most common causes include:
Hearing loss Head and neck trauma Obstructions in the middle ear Ototoxic drugs Sinus pressure and barometric trauma Temporomandibular joint disorder Traumatic brain injury Various diseases, infections, and medical conditions
Tinnitus is mostly subjective, which means it can be tricky to diagnose the condition. According to the ATA, an assessment by a trained audiologist is often necessary to determine the underlying cause. The assessment can include a speech recognition test, pure tone audiogram, tympanogram, acoustic reflex testing, and otoacoustic emission testing.
“Data is still early on the links between COVID-19 and tinnitus,” Lim says. “COVID-19 treatments might lead to tinnitus, but isolation, depression, and anxiety due to the pandemic might lead to those with tinnitus to be more focused on it, might lead to an increase in symptoms. A lot of this is happening.”
There is no cure for tinnitus, but there are several treatment options, including:
Behavioral therapies: Tinnitus can cause depression, anxiety, and anger. Patients might find behavior control tools helpful for reducing their negative emotional response to the condition. General wellness: Your overall health and well-being affect the intensity of tinnitus. Improving diet, physical exercise, social activity, hobbies, and stress reduction can help manage tinnitus. Some people try natural remedies for tinnitus. Hearing aids: The majority of tinnitus symptoms are linked to hearing loss. Some patients benefit from hearing aids. Sound therapies: Patients might find relief using external noise and sounds to counteract their perception and response to tinnitus.
The Need for New Treatments
Bimodal neuromodulation as a possible treatment for tinnitus is an exciting clinical finding. However, Lim—who is also the chief scientific officer of Neuromod Device—explains that not everyone with the condition will experience improvement when using the device, and additional research is needed.
“It doesn’t fully suppress tinnitus. Not everyone benefited. Some saw improvement and some saw only slight improvement.” says Lim.
“As a clinician and scientist, I’m always open to novel approaches when it comes to tinnitus management.” Christopher Spankovich, AuD, PhD, MPH, associate professor and vice-chair of research in the department of otolaryngology and communicative sciences at the University of Mississippi Medical Center, tells Verywell. “But my enthusiasm with this study is tempered as it lacked a placebo control and a comparison to other methods to treat tinnitus.”
Future Research
Around 45 million Americans have tinnitus, and a treatment using bimodal neuromodulation could relieve symptoms for some of them. Lim says that the next step will be to study how bimodal neuromodulation changes the brain and determine which patients will benefit most from the treatment.
“My vision for this device is for it to be available for online purchase with the guidance of a trained professional,” says Lim. “I would like it to be automated, mainstream, low cost, and provide more benefit to those suffering with tinnitus.”
Research is currently halted due to COVID-19 and 50% of the lab is shut down. The researchers are hoping to resume their studies in the spring.
